CA2284829A1 - Immunotherapy of b-cell malignancies using anti-cd22 antibodies - Google Patents

Immunotherapy of b-cell malignancies using anti-cd22 antibodies Download PDF

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Publication number
CA2284829A1
CA2284829A1 CA002284829A CA2284829A CA2284829A1 CA 2284829 A1 CA2284829 A1 CA 2284829A1 CA 002284829 A CA002284829 A CA 002284829A CA 2284829 A CA2284829 A CA 2284829A CA 2284829 A1 CA2284829 A1 CA 2284829A1
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Prior art keywords
antibody
group
immunoconjugate
conjugated
therapeutic
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CA002284829A
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French (fr)
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CA2284829C (en
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David M. Goldenberg
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Immunomedics Inc
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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Abstract

B-Cell malignacies, such as the B-cell subtype of non-Hodgkin's lymphoma and chronic lymphocytic leukemia, are significant contributors to cancer mortality. The response of B-cell malignancies to various forms of treatment is mixed. Traditional methods of treating B-cell malignancies, including chemotherapy and radiotherapy, have limited utility due to toxic side effects. Immunotherapy with anti-CD20 antibodies have also provided limited success. The use of antibodies that bind with the CD22 antigen, however, provides an effective means to treat B-cell malignancies such as indolent and aggressive forms of B-cell lymphomas, and acute and chronic forms of lymphatic leukemias. Moreover, immunotherapy with anti-CD22 antibodies requires comparatively low doses of antibody protein, and can be used effectively in multimodal therapies.

Claims (39)

1. Use of at least one entire anti-CD22 antibody that is not conjugated to a therapeutic agent, in the preparation of a medicament for use in a method of treating a B-cell malignancy, wherein, in said method, a subject having a B-cell malignancy is administered a therapeutically effective amount of the entire anti-CD22 antibody that is not conjugated to a therapeutic agent.
2. Use of at least one entire anti-CD22 antibody that is not conjugated to a therapeutic agent, in treating a B-cell malignancy.
3. A method for treating a B-cell malignancy, comprising the step of administering to a subject having a B-cell malignancy a therapeutic composition comprising a pharmaceutically acceptable carrier and at least one entire anti-CD22 antibody that is not conjugated to a therapeutic agent.
4. The use of claim 1 or 2, or the method of claim 3, wherein said anti-CD22 antibody is parenterally administered in a dosage of 20 to 100 milligrams protein per dose.
5. The use of claim 1 or 2, or the method of claim 3, wherein a subject receives anti-CD22 antibody as repeated parenteral dosages of 20 to 100 milligrams protein per dose.
6. The use of claim 1 or 2, or the method of claim 3, wherein said anti-CD22 antibody is selected from the group consisting of subhuman primate antibody, murine monoclonal antibody, chimeric antibody, and humanized antibody.
7. The use of claim 1 or 2, or the method of claim 3, wherein said anti-CD22 antibody is the LL2 antibody.
8. The use of claim 1 or 2, or the method of claim 3, wherein said B-cell malignancy is selected from the group consisting of indolent forms of B-cell lymphomas, aggressive forms of B-cell lymphomas, chronic lymphatic leukemias, and acute lymphatic leukemias.
9. The use of claim 1 or 2, or the method of claim 3, wherein said B-cell malignancy is a non-Hodgkin's lymphoma.
10. The method of claim 3, wherein said therapeutic composition comprises at least two monoclonal antibodies that bind with distinct CD22 epitopes, wherein said CD22 epitopes are selected from the group consisting of epitope A, epitope B, epitope C, epitope D and epitope E.
11. The method of claim 3, further comprising the step of administering a therapeutic protein or chemotherapeutic treatment, wherein said therapeutic protein is selected from the group consisting of antibody, immunoconjugate, antibody-immunomodulator fusion protein and antibody-toxin fusion protein.
12. The method of claim 11, wherein said therapeutic protein or said chemotherapeutic treatment is administered prior to the administration of said anti-CD22 antibody.
13. The method of claim 11, wherein said therapeutic protein or said chemotherapeutic treatment is administered concurrently with the administration of said anti-CD22 antibody.
14. The method of claim 11, wherein said therapeutic protein or said chemotherapeutic treatment is administered after the administration of said anti-CD22 antibody.
15. The method of claim 11, wherein said chemotherapeutic treatment consists of the administration of at least one drug selected from the group consisting of cyclophosphamide, etoposide, vincristine, procarbazine, prednisone, carmustine, doxorubicin, methotrexate, bleomycin, dexamethasone, phenyl butyrate, brostatin-1 and leucovorin.
16. The method of claim 11, wherein said therapeutic protein is either an entire anti-CD19 antibody that is not conjugated to a therapeutic agent or an entire anti-CD20 antibody that is not conjugated to a therapeutic agent.
17. The method of claim 11, wherein said therapeutic protein is a radiolabeled immunoconjugate.
18. The method of claim 17, wherein said radiolabeled immunoconjugate comprises a radionuclide selected from the group ~
consisting of 198Au, 32P, 125I, 131I, 90Y, 186Re, 188Re, 67Cu, and 211At.
19. The method of claim 18, wherein said radiolabeled immunoconjugate comprises an antibody or antibody fragment that binds an antigen selected from the group consisting of CD19, CD20 and CD22.
20. The method of claim 19, wherein said radiolabeled immunoconjugate is a radiolabeled anti-CD22 immunoconjugate.
21. The method of claim 20, wherein said radiolabeled anti-CD22 immunoconjugate further comprises a cytokine moiety, wherein said cytokine moiety is selected from the group consisting of interleukin-1 (IL-1), IL-2, IL-3, IL-6, IL-10, IL-12, interferon-.alpha., interferon-.beta., and interferon-.gamma..
22. The method of claim 11, wherein said therapeutic protein is an immunoconjugate or antibody-toxin fusion protein that comprises a toxin selected from the group consisting of ricin, abrin, ribonuclease, DNase I, Staphylococcal enterotoxin-A, pokeweed antiviral protein, gelonin, diphtherin toxin, Pseudomonas exotoxin, and Pseudomonas endotoxin.
23. The method of claim 22, wherein said immunoconjugate or said antibody-toxin fusion protein comprises an antibody or antibody fragment that binds an antigen selected from the group consisting of CD19, CD20 and CD22.
24. The method of claim 11, wherein said therapeutic protein is an immunoconjugate or a fusion protein, wherein said immunoconjugate or fusion protein comprises an immunomodulator moiety selected from the group consisting of interleukin-1 (IL-1), IL-2, IL-3, IL-6 and IL-10, IL-12, interferon-.alpha., interferon-.beta., interferon-.gamma., granulocyte-colony stimulating factor, granulocyte macrophage-colony stimulating factor and lymphotoxin.
25. The method of claim 24, wherein said immunoconjugate or said antibody-immunomodulator fusion protein binds an antigen selected from the group consisting of CD19, CD20 and CD22.
26. A method for treating a B-cell malignancy as claimed in claim 3, wherein said therapeutic composition comprises a combination of at least one entire anti-CD22 antibody that is not conjugated to a therapeutic agent and an anti-CD19 antibody, a combination of at least one entire anti-CD22 antibody that is not conjugated to a therapeutic agent and an anti-CD20 antibody, or a combination of at least one entire anti-CD22 antibody that is not conjugated to a therapeutic agent, an anti-CD19 antibody and an anti-CD20 antibody.
27. The method of claim 26, wherein said anti-CD19 antibody is an entire anti-CD19 antibody that is not conjugated to a therapeutic agent.
28. The method of claim 26, wherein said anti-CD20 antibody is an entire anti-CD20 antibody that is not conjugated to a therapeutic agent.
29. The method of claim 17, wherein said radiolabeled anti-CD22 immunoconjugate further comprises a colony stimulating factor, wherein said colony stimulating factor is selected from the group consisting of granulocyte-colony stimulating factor (G-CSF) and granulocyte macrophage-colony stimulating factor (GM-CSF).
30. The use of claim 1 or 2, where said anti-CD22 antibody has the antigen-binding specificity of the LL2 antibody.
31. The use of claim 1 or 2, wherein said therapeutic composition comprises at least two monoclonal antibodies that bind with distinct CD22 epitopes, wherein said CD22 epitopes are selected from the group consisting of epitope A, epitope B, epitope C, epitope D and epitope E.
32. The use of claim 1 or 2, wherein said B-cell malignancy is selected from the group consisting of indolent forms of B-cell lymphomas, aggressive forms of B-cell lymphomas, chronic lymphatic leukemias, and acute lymphatic leukemias.
33. The use of claim 1 or 2, further comprising the step of administering a therapeutic protein or chemotherapeutic treatment, wherein said therapeutic protein is selected from the group consisting of antibody, immunoconjugate, antibody-immunomodulator fusion protein and antibody-toxin fusion protein.
34. The use of claim 33, wherein said therapeutic protein is either an anti-CD19 antibody or an CD20 antibody.
35. The use of claim 34, wherein said anti-CD19 antibody is an entire anti-CD19 antibody that is not conjugated to a therapeutic agent and said anti-CD20 antibody is an entire CD20 antibody that is not conjugated to a therapeutic agent.
36. The use of claim 33, wherein said therapeutic protein is a combination of at least one anti-CD19 antibody and at least one anti-CD20 antibody.
37. The use of claim 36, wherein said anti-CD19 antibody is an entire anti-CD19 antibody that is not conjugated to a therapeutic agent and said anti-CD20 antibody is an entire CD20 antibody that is not conjugated to a therapeutic agent.
38. The use of claim 33, wherein said therapeutic protein is an immunoconjugate or a fusion protein, wherein said immunoconjugate or fusion protein comprises an immunomodulator moiety selected from the group consisting of interleukin-1 (IL-1), Il-2, IL-3, Il-6 and IL-10, IL-12, interferon-.alpha., interferon-.beta., interferon-.gamma., granulocyte-colony stimulating factor, granulocyte macrophage-colony stimulating factor and lymphotoxin.
39. The use of claim 33, wherein said immunoconjugate comprises a colony stimulating factor selected from the group consisting of granulocyte-colony stimulating factor (G-CSF) and granulocyte macrophage-colony stimulating factor (GM-CSF).
CA2284829A 1997-03-24 1998-03-17 Immunotherapy of b-cell malignancies using anti-cd22 antibodies Expired - Lifetime CA2284829C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US4150697P 1997-03-24 1997-03-24
US60/041,506 1997-03-24
PCT/US1998/005075 WO1998042378A1 (en) 1997-03-24 1998-03-17 Immunotherapy of b-cell malignancies using anti-cd22 antibodies

Publications (2)

Publication Number Publication Date
CA2284829A1 true CA2284829A1 (en) 1998-10-01
CA2284829C CA2284829C (en) 2012-10-23

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Country Status (12)

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US (1) US6183744B1 (en)
EP (4) EP1459768A3 (en)
JP (2) JP4584363B2 (en)
AT (1) ATE297759T1 (en)
AU (1) AU728325B2 (en)
CA (1) CA2284829C (en)
DE (1) DE69830570T3 (en)
DK (1) DK0969866T4 (en)
ES (1) ES2241129T5 (en)
IN (1) IN189313B (en)
WO (1) WO1998042378A1 (en)
ZA (1) ZA982438B (en)

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